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| Product NDC Code | 79903-033 | ||||
|---|---|---|---|---|---|
| Drug Name | Anticavity |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | RINSE | ||||
| RxCUI drug identifier | 240698 | ||||
| Application Number | M021 | ||||
| Labeler Name | Wal-Mart | ||||
| Packages |
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.Adverse reaction Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Sodium fluoride 0.05% (0.02% w/v fluoride ion)
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions Adults and children 6 years and older: use once a day after brushing your teeth with toothpaste vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out do not swallow the rinse do not eat or drink for 30 minutes after rinsing instruct children under 12 years of age in good rinsing habits (to minimize swallowing) supervise children as necessary unitl capable of using without supervision Children under 6 years of age: consult a dentist or doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, green 3, poloxamer 407, polysorbate 80, propylene glycol, sodium benzoate, sodium phosphate, sorbitol, sucralose, water, yellow 5
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Use aids in the prevention of dental cavities
Purpose
Information about the drug product’s indications for use.Purpose Anticavity
Spl product data elements
Usually a list of ingredients in a drug product.Anticavity Sodium fluoride BENZYL ALCOHOL EDETATE CALCIUM DISODIUM ANHYDROUS CETYLPYRIDINIUM CHLORIDE EDETATE DISODIUM ANHYDROUS SODIUM PHOSPHATE, DIBASIC, ANHYDROUS FD&C GREEN NO. 3 POLOXAMER 407 POLYSORBATE 80 PROPYLENE GLYCOL SODIUM BENZOATE SODIUM PHOSPHATE SORBITOL SUCRALOSE WATER FD&C YELLOW NO. 5 SODIUM FLUORIDE FLUORIDE ION
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.principal display panel NDC 79903-033-44 KIDS equate Compare to Act Wild Watermelon Kids Anticavity Fluoride Rinse active ingredient* Sugar-free WATERMELON FLAVOR Kids Anticavity Fluoride Rinse Alcohol FREE IMPORTANT: Read directions for proper use 18 FL OZ (1 PT 2 FL OZ) 532 mL image description
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Other information store at room temperature
Disclaimer *This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Act ® Wild Watermelon Anticavity Kids Fluoride Rinse. Made in the USA with domestic and imported ingredients Factory Certified
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If more than used for rinsing is accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.TAMPER EVIDENT STATEMENT Sealed with printed neckband for your protection
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions Satisfaction guaranteed - For questions or comments please call 1-888-287-1915.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings for this product
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API